PEG Hydrogel Coating for Bioprosthetic Valve Biocompatibility

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Solution Overview

Problem

Bioprosthetic valves often face compatibility issues due to interactions with blood components, leading to complications and reduced patient outcomes, as existing surface modifications are inadequate in creating a non-thrombogenic and non-immunogenic environment.

Innovation Solution

A two-step surface coating method using polyethylene-glycol (PEG)-based hydrogel coatings is applied to bioprosthetic valves, incorporating heterobifunctional linker molecules and PEGDA polymerization initiated by glucose oxidase and iron(II) sulfate, creating a customizable, non-fouling surface that promotes endothelialization and maintains mechanical properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bioprosthetic valves are made from xenogeneic tissue to provide functional valve replacement, then valve functionality is achieved, but biocompatibility issues arise due to interactions with blood components causing thrombogenicity and immunogenicity

Engineering Contradiction:
Improvevalve functionalityVSAvoidthrombogenicity and immunogenicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies composite materials by combining xenogeneic valve tissue with a PEG-based hydrogel coating layer. This composite structure maintains the functional properties of the xenogeneic tissue while the PEG hydrogel layer provides non-thrombogenic and non-immunogenic properties, resolving the contradiction between functionality and biocompatibility

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The PEG-based hydrogel coating creates an inert, non-fouling surface environment that prevents unwanted interactions between blood components and the xenogeneic tissue. This inert surface layer eliminates thrombogenicity and immunogenicity while preserving valve functionality

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Object-affected harmful factors

If surface modifications are applied to reduce interactions with blood components, then biocompatibility improves, but existing modifications are inadequate in creating a sufficiently non-thrombogenic and non-immunogenic environment

Engineering Contradiction:
Improvereduced interactions with blood componentsVSAvoidnon-thrombogenic and non-immunogenic environment
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent changes the surface parameters by introducing a PEG-based hydrogel coating with specific properties (non-fouling, non-thrombogenic, non-immunogenic characteristics). This parameter change transforms the surface from thrombogenic to non-thrombogenic, achieving the desired biocompatibility level

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The PEG-based hydrogel coating acts as an intermediary layer between the xenogeneic tissue and blood components. This mediator prevents direct interactions that cause thrombogenicity and immunogenicity, creating the required non-thrombogenic and non-immunogenic environment

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a surface coating is applied to improve biocompatibility, then non-fouling properties are achieved, but the coating must maintain the mechanical properties of the underlying valve structure

Engineering Contradiction:
Improvenon-fouling propertiesVSAvoidmechanical properties of the valve
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent uses a thin PEG-based hydrogel film that conforms to the valve structure. This thin flexible coating provides non-fouling properties while being thin enough to maintain the underlying valve's mechanical properties and structural integrity

Inventive Principle:
Principle #30Flexible shells and thin films

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The coating significantly reduces fouling and thrombogenicity, creating a long-term non-thrombogenic, non-immunogenic environment without altering the mechanical properties of the valve, thus improving patient outcomes and compatibility.

Implementation Method 1

PEGDA polymerization initiated by glucose oxidase and iron(II) sulfate

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 2

glucose oxidase and iron(II) sulfate

Methodology Applied
Scientific EffectFenton reaction: Redox Reactions

Implementation Method 3

reducing or eliminating interactions between blood components, such as cells, proteins, platelets

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS10322208B2Surface coating method to improve implantable device biocompatibility
Publication Date: 2019.06.18 WILLIAM MARCH RICE UNIVERSITY
  • US10322208B2 patent drawing
  • US10322208B2 patent drawing
  • US10322208B2 patent drawing

AI summary

Techniques for modifying the surface of implantable devices, such as bioprosthetic valves, to improve the biocompatibility of the implantable devices are provided. In particular, a customizable, non-fouling surface coating may be formed on the surface of implantable devices that improves the biocompatibility of the implantable devices and has the potential to further reduce the occurrence of complications for patients of all ages. Additionally, various molecules of interest to specifically promote endothelialization of the implantable device may be added to the surface coating, which may facilitate the formation of an endothelial layer on the surface of the implantable device that would naturally maintain a non-thrombogenic, non-immunogenic environment in the long-term.